Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

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Brief Title

Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

Official Title

Multi-Center, Randomized, Controlled Evaluation of the Safety & Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

Brief Summary

      The objectives of this study are to evaluate and compare the safety and efficacy of three
      treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin
      ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing
      maximum corneal curvature.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Mean change in maximum corneal curvature (Kmax) from baseline

Secondary Outcome

 Comparison of treatment groups within each treatment indication

Condition

Keratoconus

Intervention

KXL System (15 mW/cm2)

Study Arms / Comparison Groups

 VibeX Treatment Group A
Description:  Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

1721

Start Date

July 2012

Completion Date

August 2016

Primary Completion Date

January 2016

Eligibility Criteria

        Inclusion Criteria (all subjects):

          1. Be at least 12 years of age, male or female, of any race;

          2. Provide written informed consent and sign a HIPAA form. Patients who are under the age
             of 18 will need to sign an assent form as well as having a parent or legal guardian
             sign an informed consent;

          3. Willingness and ability to follow all instructions and comply with schedule for
             follow-up visits;

          4. For females capable of becoming pregnant, agree to have urine pregnancy testing
             performed prior to randomization of the study eye and on the day of the fellow eye
             treatment (which occurs between the 3 to 6 month study eye visits); must not be
             lactating, and must agree to use a medically acceptable form of birth control for at
             least one week prior to the randomization visit and continue to use the method until
             one month after the last dose of test article. Acceptable forms for birth control are
             spermicide with barrier, oral contraceptive, injectable or implantable method of
             contraception, transdermal contraceptive, intrauterine device, or surgical
             sterilization of partner. For non-sexually active females, abstinence will be
             considered an acceptable form of birth control. Women considered capable of becoming
             pregnant include all females who have experienced menarche and have not experienced
             menopause (as defined by amenorrhea for greater than 12 consecutive months) or have
             not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal
             ligation, or bilateral oophorectomy);

          5. BSCVA of ≥1 letter and ≤80 letters on ETDRS chart;

          6. Presence of central or inferior steepening on the topographic map;

          7. Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period
             prior to the screening visit(s);

          8. Contact Lens Wearers Only: manifest refraction must be stable between two visits which
             occur at least 7 days apart. A stable refraction is one in which the manifest
             refraction spherical equivalent and the average K (Km) on the topographer taken at the
             first visit do not differ by more than 0.75 D from the respective measurements taken
             at the second exam;

             Inclusion Criteria (keratoconus subjects only):

          9. Have a maximum corneal curvature as measured by Kmax of ≥ 47.00 D;

         10. Having topographic evidence of keratoconus with a diagnosis of mild, moderate or
             severe keratoconus defined as the following:

               -  Mild Keratoconus

                    1. Axial topography consistent with keratoconus

                    2. Flat keratometry reading ≤ 51.00 D on topography map

               -  Moderate Keratoconus

                    1. Axial topography consistent with keratoconus

                    2. Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on
                       topography map

               -  Severe Keratoconus:

                    1. Axial topography consistent with keratoconus with marked areas of steepening

                    2. Flat keratometry reading ≥ 56.01 D on topography map

             Inclusion Criteria (corneal ectasia subjects only):

         11. Having a diagnosis of corneal ectasia after refractive surgery;

         12. Having axial topography consistent with ectasia;

        Exclusion Criteria (all subjects):

          1. Contraindications, sensitivity or known allergy to the test article(s) or their
             components;

          2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine
             pregnancy test prior to the randomization or treatment of either eye or during the
             course of the study;

          3. Corneal pachymetry that is < 375 microns prior to epithelial debridement at the
             thinnest point in the eye to be treated;

          4. Eyes which are aphakic;

          5. Eyes which are pseudophakic and do not have a UV blocking lens implanted;

          6. Previous ocular condition (other than refractive error) in the eye to be treated that
             may predispose the eye for future complications. For example:

               1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis,
                  recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)

               2. Clinically significant corneal scarring in the cross-linking treatment zone that
                  is not related to keratoconus or corneal ectasia, in the investigator's opinion,
                  will interfere with the cross-linking procedure;

          7. A history of delayed epithelial healing in the eye(s) to be treated;

          8. Patients with nystagmus or any other condition that would prevent a steady gaze during
             the treatment or other diagnostic tests;

          9. Patients with a current condition that, in the investigator's opinion, would interfere
             with or prolong epithelial healing;

         10. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking
             treatment.

         11. A history of previous corneal crosslinking treatment in the eye to be treated;

         12. Have used an investigational drug or device within 30 days of the study or be
             concurrently enrolled in another investigational drug or device trial within 30 days
             of the study;

         13. A history of previous corneal surgery (other than LASIK or PRK for subjects with
             corneal ectasia) or the insertion of Intacs in the eye(s) to be treated;

         14. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be
             treated;

         15. In addition, the Investigator may exclude or discontinue any subject for any sound
             medical reason;

             Exclusion Criteria (Keratoconus subjects only):

         16. Eyes classified as either normal, atypical normal, or keratoconus suspect on the
             severity grading scheme.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John Vukich, MD, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT01459679

Organization ID

ACOS-KXL-001


Responsible Party

Sponsor

Study Sponsor

American-European Congress of Ophthalmic Surgery


Study Sponsor

John Vukich, MD, Principal Investigator, American-European Congress of Ophthalmic Surgery


Verification Date

June 2018